Device for evacuating and/or monitoring gas leaking from a patient during surgery or anesthetization

ABSTRACT

A system is described herein for evacuating gas as it is leaking from a patient&#39;s airway. The system comprises a gas evacuation flowpath configured for collecting a gas flow escaping from the patient when inserted into the patient&#39;s airway. A vacuum source is connected to the gas evacuation flowpath. Devices that may be employed as part of the system and a method for evacuating gas from a patient are also described.

PRIORITY CLAIMS

This present application is a divisional of U.S. application Ser. No.13/940,175, filed Jul. 11, 2013, which claims priority benefit to U.S.Provisional Application No. 61/670,462, filed Jul. 11, 2012; and U.S.Provisional Application No. 61/776,209, filed Mar. 11, 2013 thedisclosures of all of which are incorporated herein by reference intheir entirety.

FIELD OF THE DISCLOSURE

This invention relates generally to the field of medicine and morespecifically to a device for monitoring and evacuating gas that leakspast a seal on an intubation device inserted into a patient duringsurgery or a patient who is otherwise in need of breathing support.

BACKGROUND

For patients undergoing surgery, or those that require prolongedrespiratory support, inhaled gases (oxygen, nitrogen), and inhalationanesthetic agents are used routinely. These gases are delivered via aclosed system, with a goal to retain the inhaled and exhaled gaseswithin the closed system.

The general concept of scavenging anesthetic gases is well known. Inanesthetic gas systems that administrate highly toxic gases such ashalogenated ethers, it has been known for some time that thesesubstances are harmful. Gas systems have been designed to minimize theexposure of the operating room personnel to these gases. Closedbreathing circuits are specifically designed to create a closed systemwhereby the gas that is breathed in by the patient is subsequentlyreturned via a closed circuit back to the gas administration system.These systems are generally focused on recovering or reusing theanesthetic gases or at least scrubbing them from the air before the airis vented.

One consistent area of leakage of these gases occurs at the interfacebetween the patient's airway and the device delivering the gases. Theinterface is characterized by an incomplete seal between the patient'stissues and the inserted endotracheal tube or laryngeal mask airway(“LMA”).

Leakage of these gases is not without risk, both in the short term andlong term. Short term leakage of oxygen is a direct risk to patients,especially in settings where electrical current and electric instrumentsare present. Oxygen is a fire accelerant, and significant leakage inhealth care settings can lead to catastrophic fires. These fires canburn the inside of the lungs, as well as other portions of the patient'sbody. In addition to the risks to the patient, the operating room andother hospital staff are also at risk of burn/inhalation injury.

Long term risks of anesthetic gas leakage are also a concern to hospitaloperating room and critical care unit staff. Recent research hasdemonstrated increase concentrations of inhalation anesthetics inoperating room staff. The long term exposure risks to these agents havenot been clarified in the research literature, but many of these agentshave documented tissue toxicity, including neuro-toxicity. Recentresearch has highlighted these concerns, and raised questions abouttoxicity with chronic exposure, even at low concentrations.

Current endotracheal tubes (“ETT”) and laryngeal mask airway (“LMA”)designs (including nasal trumpets for certain difficult cases) oftenhave features that partially address the issue of surgical gas leakage.For example, ETT often use an inflatable cuff to limit leakage from apatient's airway during surgery. While these inflatable cuffs arepartially effective, they often do not fully seal, thus resulting inunwanted leakage of the surgical gases from the patient. In addition,the inflation pressure for the inflatable cuff around the airway cancause tissue damage to the windpipe/trachea, if the pressure is inflatedto high. Low pressure in the inflatable cuff is less damaging to thewindpipe, but it allows for a less secure airway seal.

To provide an improved fit of the seal around the airway and therebylimit leakage, both the ETT and LMA are available in different sizes.However, even properly fitted seals can allow for leakage of surgicalgas from a patient's airway. Because of significant anatomic variationseen in the airway and due to the vascular nature of the tissue,obtaining a perfect seal in the majority of cases can be difficult. Forthis reason, at least small amounts of gas leakage is common.

As mentioned above, a patient's body does not always create a perfectmatch to a closed breathing circuit and as a result, gas may leak fromthe breathing circuit from time to time or in some cases continuously.It would be a step forward in the art to provide a means for capturingthese gases when and if they leak from a closed breathing circuit withina patient's throat or nares.

SUMMARY

The present disclosure is directed to various embodiments, among whichinclude the following directed to a system for evacuating gas as it isleaking from a patient's airway:

-   -   1.01 A system for evacuating gas as it is leaking from a        patient's airway, the system comprising: a gas evacuation        flowpath configured for collecting a gas flow escaping from the        patient when inserted into the patient's airway; and a vacuum        source connected to the gas evacuation flowpath.    -   1.02 The system of claim 1.01, further comprising at least one        sensor for determining a concentration of a measured gas in the        gas flow.    -   1.03 The system of claim 1.02, wherein the at least one sensor        is fluidly connected to the gas evacuation flowpath, the at        least one sensor being capable of real time, continuous        monitoring of a gas in the gas flow that is collected from the        patient.    -   1.04 The system of claim 1.03, further comprising: a gas        monitoring device in communication with the at least one sensor,        the gas monitoring device including a component chosen from a        data logger, alarm system or monitoring screen; a vacuum        pressure valve capable of providing a vacuum to the gas        evacuation plug when it is placed inside the patient's airway;        and a connection from the vacuum pressure valve to the vacuum        source.    -   1.05 The system of claim 1.02, wherein the at least one sensor        is configured to monitor at least one of oxygen concentration,        anesthesia concentration, CO2 concentration or pH.    -   1.06 The system of claim 1.01, wherein the gas evacuation        flowpath comprises a gas evacuation plug attached to a patient        airway tube, the plug being configured to expand to fill the        patient's mouth cavity to provide a seal.    -   1.07 The system of claim 1.01, further comprising a second        flowpath configured to administer a gas to a patient.    -   1.08 The system of claim 1.07, wherein the second flowpath and        the gas evacuation flowpath are both integrated into a        multi-lumen endotracheal tube, the multi-lumen endotracheal tube        comprising a first lumen and one or more smaller lumens, the        first lumen being the second flowpath configured to deliver        anesthetic gases into and out of the lungs of a patient; and the        one or more smaller lumens being the gas evacuation flowpath        dedicated to providing vacuum pressure to evacuate gasses that        have leaked past the seal.    -   1.09 The system of claim 1.01, wherein the gas evacuation        flowpath comprises a Guedel airway modified to evacuate gas as        it is leaking from a patient's throat during surgery, the Guedel        airway comprising: a conduit providing an airway; a flange        positioned at an end of the conduit; and a plurality of vents        positioned in the conduit, the vents configured to allow gas in        a patient's throat to move into the modified Guedel airway.    -   1.10 The system of claim 1.01, wherein the gas evacuation        flowpath comprises a first tube configured to be placed through        a patient's mouth or nares; and a device positioned at or near        the end of the first tube, the device chosen from a cap or a        spacer.    -   1.11 The system of claim 1.01, wherein the gas evacuation        flowpath comprises a nasal trumpet, the nasal trumpet        comprising: a conduit providing an airway; a flange positioned        at an end of the conduit; and a plurality of vents positioned in        the conduit, the vents configured to allow gas in a patient's        airway to move into the conduit.

Other embodiments of the present disclosure are directed to a sleeve foruse with an intubation device comprising a seal, including thefollowing:

-   -   2.01 A sleeve for use with an intubation device comprising a        seal, the sleeve comprising: a plug configured to fit above the        seal in a patient's airway; a flowpath running through the plug        for evacuating surgical gases; and one or more vent positioned        in the plug, the vents configured so that when a vacuum is        applied to the conduit, evacuation of leaking surgical gas from        the patient's airway occurs through the conduit.    -   2.02 The sleeve of claim 2.01, wherein the plug is configured to        expand to fill the patient's mouth cavity to provide a secondary        seal.    -   2.03 The sleeve of claim 2.01, wherein the plug comprises foam.    -   2.04 The sleeve of claim 2.01, wherein the plug comprises open        cell foam.    -   2.05 The sleeve of claim 2.01, wherein the flowpath comprises a        connection for attaching to vacuum tubing.

Still other embodiments are directed to a device for collecting gas froma patient, including the following:

-   -   3.01 A device for collecting gas from a patient, the device        comprising: a conduit comprising a first opening, a second        opening and a flowpath between the first and second openings,        the conduit configured to be inserted into the airway of a        patient; a flange positioned proximate the first opening of the        conduit; a plurality of vents positioned in the conduit, the        vents configured to allow gas in a patient's airway to move into        the flowpath.    -   3.02 The device of claim 3.01, further comprising: a seal        positioned around the conduit, the seal configured to block a        space between the conduit and tissue lining a patient airway; a        first lumen configured to deliver anesthetic gases into and out        of the lungs of a patient; wherein the flowpath comprises one or        more smaller lumens dedicated to providing vacuum pressure to        evacuate gasses that have leaked past the seal, the one or more        smaller lumens configured concentrically around the first lumen;        and wherein the second opening is the plurality of vents in        fluid connection with the one or more smaller lumens, the vents        configured to collect gases that leak past the seal.    -   3.03 The endotracheal tube of claim 3.02, further comprising a        plug positioned on the multi-lumen endotracheal tube, the vents        being positioned between the seal and the plug.    -   3.04 The device of claim 3.01, wherein the device is configured        as a Guedel airway for insertion into a patient's throat.    -   3.05 The device of claim 3.04, wherein the flange comprises        notches that are configured to accommodate a device selected        from an endotracheal tube or LMA.    -   3.06 The device of claim 3.04, further comprising an adapter        that fits onto the Guedel airway and allows a user to attach an        operating room vacuum source to the airway.    -   3.07 The device of claim 3.01, wherein the device is configured        as a nasal trumpet for insertion into a nare of the patient.

Yet other embodiments of the present disclosure are directed to methodsfor evacuating gas as it is leaking form a patient's airway, includingthe following:

-   -   4.01 A method for evacuating gas as it is leaking from a        patient's airway, the method comprising: collecting a gas that        has leaked past a seal of closed circuit gas administration        equipment and into the patient's throat or mouth; and removing        the collected gas from the patient using a vacuum system.    -   4.02 The method of claim 4.01, further comprising determining        one of oxygen concentration, anesthesia concentration or CO2 gas        concentration in the collected gas.    -   4.03 The method of claim 4.02, further comprising administering        a gas to a patient using a patient airway tube, the patient        airway tube including the seal.    -   4.04 The method of claim 4.03, wherein the gas comprises        anesthesia.    -   4.05 The method of claim 4.03, further comprising determining        the effectiveness of the seal using the determined concentration        of the collected gas.    -   4.06 The method of claim 4.02, further comprising providing        determined oxygen concentration data to a user.    -   4.07 The method of claim 4.02, further comprising determining if        there is acid reflux in the patient's airway.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the present teachings, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the presentteachings and together with the description, serve to explain theprinciples of the present teachings.

FIG. 1 is a perspective view of a cuffed patient airway tube fitted witha foam evacuation plug inserted into a patient's throat, according to anembodiment of the present disclosure.

FIG. 2 is an exploded view showing a patient airway tube with a cuffthat is commonly used in operating rooms today; and a gas evacuationplug configured to attach to the airway tube, with a vacuum tube affixedthereto, according to an embodiment of the present disclosure.

FIG. 3 is a schematic view depicting one potential circuit layout of thedevice of FIG. 1, in conjunction with oxygen sensors and a gasmonitoring device for use in an operating room environment, according toan embodiment of the present disclosure.

FIG. 4 illustrates a multi-lumen device, according to an embodiment ofthe present disclosure.

FIG. 5 is a perspective view of a separate tube that can be placed in apatient's airway in addition to and/or adjacent to an intubation devicefor providing surgical gas to a patient, such as an endotracheal tube, alaryngeal mask airway tube, or a nasal device, according to anembodiment of the present disclosure.

FIGS. 6 and 7 illustrate Guedel airways that can be employed as a gasevacuation device, according to an embodiment of the present disclosure.

FIG. 8 is a diagram of a standard Guedel Airway.

FIG. 9 illustrates a nasal trumpet device configured to collect gas froma patient, according to an embodiment of the present disclosure.

It should be noted that some details of the figure have been simplifiedand are drawn to facilitate understanding of the embodiments rather thanto maintain strict structural accuracy, detail, and scale.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to embodiments of the presentteachings, examples of which are illustrated in the accompanyingdrawings. In the drawings, like reference numerals have been usedthroughout to designate identical elements. In the followingdescription, reference is made to the accompanying drawing that forms apart thereof, and in which is shown by way of illustration a specificexemplary embodiment in which the present teachings may be practiced.The following description is, therefore, merely exemplary.

An embodiment of the present disclosure is directed to a system forsafely capturing surgical gases that have leaked past a seal that isengineered into a patient airway tube, such as an endotracheal tube,laryngeal airway mask, nasal trumpet or nasal tube, or other similardevice; and to remove these gases from the patient without allowing themto disperse into the operating room. Oxygen/gas removal cansignificantly lower the risk for surgical fire and patient burns (e.g.,burns in the lungs, airway/mouth, face, neck or shoulders). As anexample, the seal can be formed using an inflated cuff, as is well knownin the art.

In addition, the system can optionally include the ability to measurethe amount of gas leakage that is occurring in real time and to show theoperating room staff the current status of the tube seal at any giventime. For example, the oxygen that is evacuated by the device may bemonitored. Because the concentration ratio of oxygen to anesthetic gasesin the leaking surgical gas is a known parameter, the system can use themonitored oxygen to calculate the total amount of leaking surgical gasesand thereby provide feedback to the anesthesiologist about the relativevolume of any leaks. In a similar manner, the exhaled anesthetic gasconcentrations could also be measured to provide an indication of themagnitude of gas leakage while the patient is under anesthesia. One ofordinary skill in the art would readily be able to determine themagnitude of gas leakage given the exhaled anesthetic gasconcentrations. Based on this data, the appropriate protocols toprioritize the patient's and the operating room staff's safety can bedetermined.

FIG. 1 illustrates a vented sleeve 100, according to an embodiment ofthe present disclosure. Sleeve 100 is configured to slip over anexisting intubation device 102, which can be an endotracheal tube orlaryngeal airway mask. Sleeve 100 fits above a seal 104 of the existingdevice in the patient's throat or mouth. One or more vents 106 areconfigured so that when a slight vacuum is applied to the operator endof the sleeve, evacuation of leaking surgical gas from the patient'sthroat or mouth through the attached conduit 108 results. FIG. 2provides an exploded view showing patient airway tube 102 with a cuff,or seal 104, which is commonly used in operating rooms today. A sleeve100 is shown configured to attach to the patient airway tube. A vacuumtube 108 is affixed thereto, according to an embodiment of the presentdisclosure.

In an embodiment, the sleeve 100 can comprise an expandable plug 110.Expandable plug 110 can comprise any suitable material. In oneembodiment, the material is foam, such as an open cell foam, which iscapable of expanding to fill the patient's mouth cavity to provide asecondary seal. Alternatively, plug 110 can comprise any other suitablematerial that can provide the desired secondary seal. In an embodiment,a flow path for evacuating the surgical gases can extend through theplug 110. Conduit 108 can attach to and/or extend through plug 110 aspart of the flowpath. Conduit 108 can comprise any suitable material andcan be, for example, vacuum tubing.

FIG. 3 illustrates a system 120 for monitoring gases in an operatingroom environment, according to an embodiment of the present disclosure.The system 120 comprises a patient airway tube 102 having a seal 104. Asleeve 100 is attached to tube 102. In an embodiment, the tube 102 andsleeve 100 can be those described above in connection with FIGS. 1 and2.

One or more sensors 122 are fluidly connected to the sleeve 100. The oneor more sensors are capable of real time, continuous monitoring of a gasthat is drawn from a patient using the sleeve 100. In an embodiment, thegas being sensed can be chosen from oxygen gas, CO₂ or anesthesia. Gassensors 122 can also be used to determine pH of the gas evacuated fromthe patient.

The sensed gas levels coming from the patient can be compared to, forexample, ambient levels of gases, such as CO₂ or oxygen, in theoperating room. For example, sensors 122 can be kept in a container thatis separate from the ambient operating room atmosphere. Gas that isdrawn from the patient can be compared to the ambient levels of oxygenin the operating room. If sensors 122 indicate higher oxygenconcentrations in the gas drawn from the patient relative to the ambientlevels, this would be indicative to the operator that a leak of surgicalgases is occurring. Alternatively, in an embodiment employing a sensorthat measures anesthetic gases directly, the sensor can provide a directindication of any gas leakage without the need for comparison withambient oxygen levels.

A gas monitoring device 124 can be in communication with the one or moresensors 122. Gas monitoring device 124 can include a component chosenfrom, for example, a data logger, alarm system or monitoring screen.

A vacuum pressure valve 126 is employed to provide a steady and suitablylow level of vacuum pressure to the gas evacuation plug while it isplaced inside the patient's throat or oral cavity. Vacuum pressure valve126 can be connected to the operating rooms vacuum evacuation facilityat, for example, point “A”.

As discussed above, the ability to provide a slight vacuum sufficient toevacuate a leaking surgical gas above a primary seal can allow thesystem to flow the leaking gas past an oxygen sensor, such as, forexample, a sensor that is placed along the evacuation line itself.Because surgical gases comprise at least some oxygen, the system can beused to determine when the surgical gases are being leaked from thepatient. For example, by measuring the concentration of oxygen in thegas and correlating it to the level of oxygen that is being used forthat patient, the operator can monitor the relative amount of gas thatis leaking from the patient at any given time. In an embodiment, thisdata can be provided to the operator in the form of a screen chartingthe trend line of the oxygen concentration of the gas that is beingevacuated relative to the oxygen concentration in the operating roomitself. In a similar manner, monitoring the concentrations of leakedanesthetic gases can also be used to determine the magnitude of the gasleak.

Charting this trend line can aid in several different aspects of theoperating room's case management. Large volumes of enriched oxygenleaking into the operating room can be hazardous with regard to creatinga fire hazard or an environment where flash fires can occur. This isboth dangerous for patients and for operating room personnel. Beinginformed of leaking oxygen can serve to allow the anesthesiologist tolimit the amount of gas escaping into the operating room and/or to takesteps to prevent the buildup of such gases to dangerous levels.

As part of this process, the identification of a leak around the cuff ofan endotracheal tube or other such device allows the operator toslightly increase the pressure on the inflatable cuff such that theminimum amount of inflation can be used to create an effective seal.This is an improvement over current practice, in that too much cuffinflation can cause harm to the patient's vocal cords and airway tissue,and discomfort to the patient. By determining the amount of pressurethat can be employed to maintain an effective seal, an operator usingthis system would be able to accurately and continuously monitor theamount of pressure that is being used to inflate the cuff to insure theminimal level of patient discomfort or harm.

The system can also include the ability to notify the operating roompersonnel about anesthesia gas leakage by detecting the presence ofincreased concentration of CO₂ from the gas that leaks. Ambient levelsof CO₂ gas are approximately 0.03% while CO₂ in exhaled breath isapproximately 4%. Due to the higher relative concentration of CO₂ inexhaled breath, monitoring of the CO₂ gas concentration in the evacuatedgas stream coming from the patient can inform the anesthesiologist ifexhaled breath is leaking from around the seal on the patient airwaytube. The monitoring of CO₂ can indicate a leak even when enrichedoxygen is not being used during the surgery.

In addition to monitoring gas concentrations, the devices of the presentdisclosure can optionally include the ability to measure the pH leveland/or to determine if acid is refluxing from the stomach into theairway region. The pH level or change thereof can be used to warn thesurgical team of potential danger to the patient's airway. Sensing thepH can be performed in any desired manner. In an embodiment, gasescollected from the patient can be analyzed to determine pH or changes inpH, which may be used to indicate reflux in the patient's airway.Devices for sensing pH levels of a gas flow are well known in the art.In another embodiment, the devices of the present disclosure can includea small probe (not shown) that sits near the airway. Any suitable pHprobe can be employed. Suitable pH probes are well known and one ofordinary skill would readily be able to employ such probes, such as bypositioning a pH probe on any of the airway devices of the presentdisclosure. If fluid comprising acidic contents from the patient'sstomach comes into the region near the airway, the probe can identify adrop in pH. Regardless of the technique used to detect pH, the change inpH can be communicated to the operating team to make them aware of apotentially dangerous environment for the patient's airway. If theseconditions are identified, an anesthesiologist can act appropriately,such as by removing the potentially harmful fluid from near the airwayand/or by modifying the anesthesia technique appropriately to protectthe patient.

FIG. 4 illustrates an intubation device comprising a fully integratedflowpath for evacuating leaking gases, according to an embodiment of thepresent disclosure. For example, the intubation device can be in theform of an endotracheal tube comprising a multi-lumen conduit. Asillustrated in FIG. 4, an endotracheal tube can include a large lumen140 that serves to deliver anesthetic gases into and out of the lungs ofthe patients, while one or more smaller lumens 142 are dedicated toproviding vacuum pressure to evacuate any gasses that have leaked abovethe tube seal 104. Vents 144 provide fluid communication between thepatient's airway above the seal 104 and the small lumen 142, therebyallowing leaking gas to flow into the small lumen 142 and out of thepatient. Vacuum pressure can be provided by any suitable means, such asthrough conduit 108 attached to a port 146 in the multi-lumen conduit.The multi-lumen conduit can be made of any suitable material, such as,for example, PVC. The smaller lumen 142 can be in the form of aconcentric annulus or any other suitable conduit configuration.

In an alternative embodiment, it may be possible to evacuate leakinggases without a secondary seal device. For example, in the embodiment ofFIG. 4, sleeve 100 may be eliminated. Leaking gases can be collected bysimply providing a sufficient vacuum through the one or more vents 144.

FIG. 5 illustrates a tubular device 150 that can be placed eitherthrough the patient's mouth or nares separately or together with anexisting device 102 for providing surgical gases to a patient, accordingto an embodiment of the present disclosure. The tubular device 150 caninclude a cap or spacer positioned at or near the end of a tube. Forexample, the end of the tube can be fitted with a foam evacuation plug152. The foam plug 152 can reduce the likelihood of developing an areaof higher pressure suction that might damage the mucosal tissue. Thetubular device can be placed in the patient's airway in addition toand/or adjacent to, for example, an endotracheal tube, a laryngeal maskairway tube, or a nasal airway tube.

The tubular device 150 allows for evacuating and/or monitoring surgicalgases, such as oxygen and anesthetic gases that have leaked past a sealon an endotracheal tube, laryngeal mask airway tube, nasal device orother device for delivering oxygen and other gases to patients. A meanscan be employed for applying a vacuum to the tubular device 150 suchthat any oxygen or accompanying anesthetic gases that leak from aroundthe seal are drawn from the patient and evacuated from the operatingroom, similarly as described for sleeve 100 and the system of FIG. 3. Inan embodiment, tubular device 150 can replace sleeve 100 in the systemof FIG. 3.

FIGS. 6 and 7 illustrate a Guedel airway design that can be used toevacuate or scavenge gas as it is leaking from a patient's throat.Geudel airways are generally well known in the art. A conventionalGeudel airway is shown in FIG. 8. However, the Guedel airway 200, asshown in FIGS. 6 and 7, has been modified so that it can functionallyreplace the device of FIG. 1 in the system of FIG. 3. In an embodiment,the Guedel airway designs do not include a sleeve 100.

Guedel airway 200 includes vents 202 in the airway. Vents 202 areconfigured to allow gas in the patient's throat to move into themodified Guedel airway. Employing a plurality of vents 202 can provideredundant access to the airway from the patient's throat area in orderto decrease the likelihood that tissue can be sucked up against a singlevent opening when suction is applied to the airway and thereby clog theairway. If only a single opening 204 exists (as in the conventionalairway of FIG. 8) the opening 204 can potentially be suctioned upagainst soft tissue in a patient's throat area and become occluded.

A flange 206 is positioned at an end of the Geudel airway. Flange 206can be designed with notches 208 that can accommodate an endotrachealtube or LMA on either side of the Geudel airway. This can allow Geudelairway 200 to more easily sit directly adjacent to an endotracheal tubeor LMA tube when the Geudel airway end opposite flange 206 is insertedinto a patient's mouth and throat during surgery. The purpose of Geudelairway 200 is to remove gas that has leaked from, for example, anendotracheal tube or LMA seal that is also positioned in a patient'sthroat. The Geudel airway 200 can be attached to any suitable vacuumsource to provide the desired suction. FIG. 7 illustrates an example ofan adapter 210, which fits onto the Guedel airway and allows a user toeasily attach an operating room vacuum source to the airway using astandard suction tube, such as conduit 108 in FIG. 1. For example, theadapter end 212 can be designed to be inserted into hole 204 at theflanged end of the Guedel airway to form an air-tight seal. Adaptor end214 can be attached to the vacuum source. As oxygen and/or anestheticare administered to the patient through the endotracheal tube or LMA,the vacuum source can suction any leaking gases through the vents 202and hole 204 and into the Geudel airway 200. In an embodiment, theGuedel airway 200 can be used in place of the vented sleeve 100 in thesystem of FIG. 1.

Other embodiments may exist that serve to provide this samefunctionality and these same concepts may be applied to other devicesthat are used to assist patients in need of breathing assistance, suchas nasal trumpets. For example, FIG. 9 illustrates a nasal trumpet 250comprising holes 204, 214 for the main air flow, as well as vents 202,similar to the Geudel airway design, according to an embodiment of thepresent disclosure. If desired, the vents 202 can be placed in multiplepositions along the nasal trumpet to increase the amount of capturedgases from the patient and/or to reduce the chance of air flow blockagethrough the device. An adapter, such as adapter 210 of FIG. 7, can beused to provide a connection between the hole 204 of nasal trumpet 250and the vacuum source. In an embodiment, the nasal trumpet 250 can beused in place of or in addition to the vented sleeve 100 in the systemof FIG. 1. The nasal trumpet 250 is placed through the patient's nares,in addition to, or instead of using the traditional mouth area foraccess. If desired, a pH detection system as desired herein above can beused in combination with any of the airway devices of the presentdisclosure, including the nasal trumpet 250, Guedel airway 200, sleeve100, nasal tube 150 or endotracheal tube devices of FIG. 1 or 4.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the disclosure are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements. Moreover, all ranges disclosed hereinare to be understood to encompass any and all sub-ranges subsumedtherein.

While the present teachings have been illustrated with respect to one ormore implementations, alterations and/or modifications can be made tothe illustrated examples without departing from the spirit and scope ofthe appended claims. In addition, while a particular feature of thepresent teachings may have been disclosed with respect to only one ofseveral implementations, such feature may be combined with one or moreother features of the other implementations as may be desired andadvantageous for any given or particular function. Furthermore, to theextent that the terms “including,” “includes,” “having,” “has,” “with,”or variants thereof are used in either the detailed description and theclaims, such terms are intended to be inclusive in a manner similar tothe term “comprising.” Further, in the discussion and claims herein, theterm “about” indicates that the value listed may be somewhat altered, aslong as the alteration does not result in nonconformance of the processor structure to the illustrated embodiment. Finally, “exemplary”indicates the description is used as an example, rather than implyingthat it is an ideal.

It will be appreciated that variants of the above-disclosed and otherfeatures and functions, or alternatives thereof, may be combined intomany other different systems or applications. Various presentlyunforeseen or unanticipated alternatives, modifications, variations, orimprovements therein may be subsequently made by those skilled in theart which are also intended to be encompasses by the following claims.

1.-30. (canceled)
 31. A method for evacuating gas as it is leaking froma patient's airway, the method comprising: collecting a gas that hasleaked past a seal of closed circuit gas administration equipment andinto the patient's throat or mouth; and removing the collected gas fromthe patient using a vacuum system.
 32. The method of claim 31, whereinthe seal is a primary seal, the method further comprising providing asecondary seal in the patient's airway that is separate from the primaryseal, the collecting of the gas occurring between the primary seal andthe secondary seal.
 33. The method of claim 32, further comprisingadministering a gas to a patient using the airway tube, the patientairway tube including the primary seal.
 34. The method of claim 33,wherein the gas comprises anesthesia.
 35. The method of claim 33,further comprising determining one of oxygen concentration, anesthesiaconcentration or CO₂ gas concentration in the collected gas.
 36. Themethod of claim 31, further comprising determining one of oxygenconcentration, anesthesia concentration or CO₂ gas concentration in thecollected gas.
 37. The method of claim 36, further comprisingdetermining the effectiveness of the primary seal using the determinedconcentration of the collected gas.
 38. The method of claim 36, furthercomprising providing determined oxygen concentration data to a user. 39.The method of claim 31, further comprising determining if there is acidreflux in the patient's airway.
 40. The method of claim 31, wherein theclosed circuit gas administration equipment comprises an intubationdevice comprising an airway tube and the seal positioned on an outerperimeter of the airway tube, the airway tube comprising a firstflowpath configured to administer a gas to the patient, the sealpositioned in the patient's airway to block a space between the airwaytube and tissue lining the patient's airway.
 41. The method of claim 40,wherein the closed circuit gas administration equipment furthercomprises a gas evacuation flowpath comprising one or more ventspositioned in the patient's airway for collecting the gas that hasleaked past the seal, the gas evacuation flowpath being separate fromthe first flowpath.
 42. The method of claim 41, wherein the seal is aprimary seal, and further comprising providing a secondary seal in thepatient's airway that is separate from the primary seal, the one or morevents being positioned between the primary seal and the secondary seal.43. A method for evacuating gas as it is leaking from a patient'sairway, the method comprising: inserting an intubation device comprisingan airway tube and a primary seal positioned on an outer perimeter ofthe airway tube, the airway tube comprising a first flowpath configuredto administer a gas to the patient, the primary seal positioned in thepatient's airway to block a space between the airway tube and tissuelining the patient's airway; inserting a gas evacuation flowpathcomprising one or more vents into the patient, and providing a secondaryseal in the patient's airway that is separate from the primary seal, thegas evacuation flowpath being separate from the first flowpath and beinginserted so that the one or more vents are positioned in the patient'sairway between the primary seal and the secondary seal for collecting agas flow that leaks past the primary seal; collecting a gas that hasleaked past the primary seal and into the patient's throat or mouth; andremoving the collected gas from the patient using a vacuum system. 44.The method of claim 43, wherein the intubation device is an endotrachealtube.
 45. The method of claim 43, wherein the intubation device is alaryngeal mask airway.